New data for this drug company’s Parkinson’s disease treatment, its agreement with BASF Pharma who will manufacture and supply the active ingredient of NUPLAZID, and its undervalued price prompted Piper Jaffrey to upgrade the shares to “Overweight.”
Acadia Pharmaceuticals (ACAD)
from Medical Technology Letter
Acadia Pharmaceuticals (ACAD) remains on track to submit the NUPLAZID NDA for Parkinson’s disease psychosis to the FDA in H2:15. The company recently announced some key management hires that add the personnel necessary to support the planned commercial launch of NUPLAZID in the United States.
ACAD recently announced the publication of new data from its ongoing open-label safety extension study, the–d015 Study–with NUPLAZID in patients with Parkinson’s disease psychosis (PDP) in the July 31 online issue of the Journal of the American Medical Directors Association. This is the first published report evaluating the long-term impact of antipsychotics on mortality and serious adverse events in patients with PDP. Currently marketed antipsychotics are not approved for PDP and have a Black Box warning for use in elderly patients with dementia due to increased mortality and morbidity. NUPLAZID was granted Breakthrough Therapy designation from the FDA in 2014, and has the potential to be the first drug approved for the treatment of PDP in the United States.
In the -015 study, there was a significant increase in the mortality rate of patients who received concurrent treatment with a currently marketed antipsychotic (18.8 deaths per 100 person-years since the first concurrent antipsychotic dose) compared to those who received NUPLAZID only (4.5 deaths per 100 person-years). The totality of the NUPLAZID data is very strong to date and peer reviewed published data is valuable as it helps draw attention to the new drug. The additional safety data, which shows significantly fewer serious adverse events and lower mortality, will also help the drug gain market share as safety is paramount in the chronic disease setting.
ACAD is positioned for multiple near-term positive catalysts, as the NDA filing and subsequent FDA approval are up next. As a reminder, the company owns 100% of the NUPLZID, and could easily form a geographic partnership for either Europe or Japan while retaining U.S. rights. The new management hires make it much easier for ACAD to sell the drug itself in the U.S. The company remains in very good negotiating position for any partnerships and as NUPLZID gets closer and closer to the market, the potential for a buyout increases proportionately.
ACAD is a BUY under 40 with a TARGET PRICE of 55.
John McCamant, Medical Technology Stock Letter, www.bioinvest.com, August 20, 2015